In a recent case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided Federal Circuit held valid a patent directed to a schizophrenia drug, finding that the claims met the “Mayo standard”.
The patent at issue directs physicians to treat patients who have low CYP2D6 activity (an enzyme) with a lower amount of iloperidone, a drug to treat schizophrenia.
Iloperidone is metabolized by CYP2D6, thus, a patient who is characterized with lower CYP2D6 activity is more prone to iloperidone cardiac side effects.
The Court held that the patent specifically tells physicians how to connect the relationship between dosage and a patient’s genotype to find the correct treatment, and that the claims do not describe any natural factor.
According to the Court, the claims were directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” These claims differ from the claims cited in the “Mayo standard” because they recite more than a natural phenomenon since they link the activity of the enzyme CYP2D6 and a cardiac rhythm parameter.
Thus, the Court held that the claims were eligible under step 2 of the “Mayo test” (they were directed to significantly more than just a law of nature or a natural phenomenon) because the discovered results are not routine and conventional.
Judge Prost, dissented saying, “the patent was just an optimization of an existing treatment of schizophrenia, just as the claims in Mayo.”
Ultimately, the Federal Circuit held that the patent was valid.
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Silvia Salvadori, PhD